The pharmaceutical quality system of SPbSRIVS FMBA (SPbSRIVS) is based on the principles of Good Manufacturing Practice (GMP) and ISO 9001. SPbSRIVS’s pharmaceutical quality system is regulated by the Quality Manual and Quality Policy, implemented through a systematic approach to quality assurance and control, as well as by application of basic principles of continuous improvement through risk assessment, change control, deviation assessment, trend analysis and quality monitoring.
SPbSRIVS has a license for manufacture of medicinal products (pharmaceutical substances and medicines), the production site is compliant with the Good Manufacturing Practice Regulations approved by Order of the Ministry of Industry and Trade of the Russian Federation No. 916 dated June 14, 2013. Subject the license requirements of the Ministry of Industry and Trade of the Russian Federation, a certificate of compliance with the Good Manufacturing Practice Regulations was issued.
SPbSRIVS has an ISO 9001:2015 certificate for the quality management system issued by Bureau Veritas, and a certificate of compliance with requirements of GMP Medical Products for Human and Veterinary Use, Vol.4, issued by Bureau Veritas.
We consider the pharmaceutical quality system of SPbSRIVS as a chain of interrelated and interdependent processes, the management of which is aimed at achieving a common result.
The Enterprise determines the requirements for personnel competence and assesses the personnel competence. To achieve required competencies, operating procedures for external and internal personnel training have been implemented and are effectively used. These procedures apply to all personnel whose activities may affect the product quality.
Quality control of raw and auxiliary raw materials, auxiliary and packaging materials, printed materials, process media, intermediate and finished products is carried out for compliance with the requirements established in the approved specifications.
To confirm the consistency of the production process, an annual review of the quality of all manufactured medicinal and medical products is carried out on a planned basis. Based on the results of product quality reviews, the constancy of the production process is assessed, necessary corrective and preventive actions are determined, the change control is monitored, and the implementation of corrective and preventive actions for the previous period is assessed.
SPbSRIVS has developed and implemented a set of measures for occupational hygiene. Requirements for personal hygiene, health condition, behavior and clothing of the staff and visitors are documented in internal procedures.
To achieve the strategic goals of SPbSRIVS, we base our work on the following principles:
1. Customer focus
This is the most complete satisfaction of customer requirements for the services we provide and for the quality of our products.
2. Leading role of management in the arrangement of work
Leaders should be the generators of ideas and actions aimed at improving the quality of our products, services and processes, as well as an example for their employees. Top management is committed to arranging the Enterprise activities in accordance with the requirements of ISO 9001, ISO 13485, the Regulations of Good Manufacturing Practice and constantly improving the effectiveness of the pharmaceutical quality system.
3. Personnel involvement in quality work
Relations between employees and leaders are built based on justice and recognition of achievements.
The company takes care of each of their employees, striving to ensure them the best working conditions, guaranteeing decent wages for productive and conscientious work. In return, the enterprise expects the employee to use the most of his knowledge and work skills for the benefit of the company, contribute to its prosperity and care for the business reputation of the company as its own one.
The system of continuous upgrade training is the basis of high intellectual potential of employees and a significant competitive advantage for the Enterprise.
4. Process approach
We consider the management system of our Enterprise as a chain of interrelated and interdependent processes, each new process in the Enterprise’s pharmaceutical management system is included only if its implementation adds value to both the Enterprise and its products and services.
We recognize and encourage the merits of initiators and managers of improvement projects, who play an important role in creating an appropriate corporate culture, all this makes it clear that improvements in our company are welcome. This approach allows us to see the effectiveness of processes, organizational capabilities and the level of customer satisfaction, to increase the focus on the analysis and identification of root causes followed by implementation of preventive and corrective actions.
6. Cooperation with suppliers
The Enterprise works with suppliers in the spirit of partnership and mutual trust. The quality of our work and customer satisfaction depends, among other things, on our suppliers. By suppliers, we mean not only organizations supplying raw materials, materials and components for our needs, but also those providing the services we require.
7. Continuous improvement of our activities
We strive for continuous improvement, primarily due to the introduction of advanced and productive equipment as well as manufacturing technologies for our products, which allows us to meet the requirements of customers with a guaranteed quality level and at the least cost.
8. Making decisions based on the analysis results for manufacturing and management processes
The Enterprise performs continuous monitoring and measurements of ongoing manufacturing and management processes in order to develop corrective and preventive actions based on the results of monitoring and measurements. We strive to prevent the problem, rather than eliminate their consequences.
9. Risk management
The Enterprise implements a risk-based approach through risk analysis and decision-making based on risk assessment results, which makes it possible to effectively carry out preventive and improvement actions.
This policy is communicated to all employees and serves as the basis for the development of quality objectives.
The Director is the person responsible for the development and implementation of the integrated quality system in the Enterprise and delegates the appropriate rights and authorities to ensure the implementation and effective operation of the pharmaceutical quality system to the Deputy Director for Quality Management.